Following a noteworthy regulatory update, Actinium Pharmaceuticals, Inc. (NYSE: ATNM) share are gaining traction on the charts this morning. As of the latest market update, ATNM shares were trading 12.48% higher to $2.79.
Regulatory Update on Iomab-B
Regarding its Biologics License Application (BLA) submission for Iomab-B, a medication intended for individuals with active relapsed or refractory acute myeloid leukemia (r/r AML), Actinium Pharmaceuticals has just given an update. Iomab-B is intended for induction and targeted radiation conditioning. It combines a radioisotope payload of iodine-131 with an anti-CD45 monoclonal antibody.
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For durable complete remission (dCR) and other favorable secondary endpoints like safety and event free survival (EFS), the SIERRA trial demonstrated high statistical significance. However, according to FDA regulations, a head-to-head randomized trial demonstrating an overall survival benefit is necessary before the BLA filing can be submitted.
Requirements for Additional Study
The FDA has recommended that Actinium conduct a new study comparing allogeneic bone marrow transplant (BMT) using Iomab-B combined with a reduced intensity conditioning regimen of fludarabine and total body irradiation (Flu/TBI) to BMT with a regimen of cyclophosphamide plus Flu/TBI.
This study will differ from the SIERRA trial, which permitted physician choice of salvage therapies and heterogeneous conditioning regimens in the control arm. Additionally, the new study will not allow patients to crossover from the control arm—a factor that had confounded the overall survival analysis in the SIERRA trial, as nearly 60% of patients crossed over.
Actinium has presented additional analyses from the SIERRA study to the FDA, including long-term follow-up data that suggests improved overall survival and potential benefits for patients with high-risk TP53 mutations.
In spite of these initiatives, the FDA has asked for more clinical research since it has concluded that the available results from the SIERRA study do not adequately support a BLA application. Actinium is still optimistic that the SIERRA trial’s safety and effectiveness results will eventually be sufficient to support a future BLA application for Iomab-B.
